For the most recent statement by FDA on asbestos contamination and improving safety in cosmetics, please see ‘Press Announcements’.
The FDA issued a Safety Alert on March 12, 2019 warning consumers not to use certain cosmetic products that tested positive for asbestos.
The FDA continues to analyze cosmetics for asbestos contamination and will provide updates with additional information that becomes available.
Talc is an ingredient used in many cosmetics, from baby powder to blush. From time to time, FDA has received questions about its safety and whether talc contains harmful contaminants, such as asbestos.
FDA's authority over cosmetic safety
Under the Federal Food, Drug and Cosmetic Act (FD&C Act), cosmetic products and ingredients, with the exception of color additives, do not have to undergo FDA review or approval before they go on the market. Cosmetics must be properly labeled, and they must be safe for use by consumers under labeled or customary conditions of use. The law does not require cosmetic companies to share safety information with FDA.
FDA monitors for potential safety problems with cosmetic products on the market and takes action when needed to protect public health. Before we can take such action against a cosmetic, we need sound scientific data to show that it is harmful under its intended use.
Talc: What it is and how it is used in cosmetics
Talc is a naturally occurring mineral, mined from the earth, composed of magnesium, silicon, oxygen, and hydrogen. Chemically, talc is a hydrous magnesium silicate with a chemical formula of Mg3Si4O10(OH)2.
Talc has many uses in cosmetics and other personal care products; in food, such as rice and chewing gum; and in the manufacture of tablets. For example, it may be used to absorb moisture, to prevent caking, to make facial makeup opaque, or to improve the feel of a product.
Published scientific literature going back to the 1960s has suggested a possible association between the use of powders containing talc and the incidence of ovarian cancer. However, these studies have not conclusively demonstrated such a link, or if such a link existed, what risk factors might be involved. The FDA has ongoing research in this area. In addition, questions about the potential contamination of talc with asbestos have been raised since the 1970s.
Asbestos: What it is, why it’s a concern, and how to prevent its occurrence in cosmetics
Asbestos is also a naturally occurring silicate mineral, but with a different crystal structure. Both talc and asbestos are naturally occurring minerals that may be found in close proximity in the earth. Unlike talc, however, asbestos is a known carcinogen. There is the potential for contamination of talc with asbestos and therefore, it is important to select talc mining sites carefully and take steps to test the ore sufficiently.
- FDA’s formation of an interagency working group on asbestos in consumer products in the fall of 2018. The purpose of this government work group is to develop recommendations on topics related to testing methodologies, terminology, and criteria for data interpretation that can be applied to characterize mineral fibers present as contaminants in consumer products.
- Joint Institute for Food Safety and Applied Nutrition (JIFSAN) scientific/technical meeting. On November 28, 2018, FDA and other government agency representatives attended a scientific and technical symposium designed to provide a forum for scientists to share their knowledge and experience in testing methods for analysis of talc, developing criteria used for fiber identification, and interpreting data. The full transcripts from the symposium can be found in the CFSAN Electronic Reading Room.
FDA's Investigation of Reports of Asbestos Contamination in Cosmetics 2017-2019
The FDA sampled cosmetic products following reports of asbestos contamination in talc-containing cosmetics. Testing of the samples was conducted on behalf of FDA by the Occupational Safety and Health Administration (OSHA) and AMA Analytical Services, Inc. (AMA).
The current findings from this testing can be found in the CFSAN Electronic Reading Room.
FDA's Talc Survey of 2009-2010
FDA contracted with AMA Analytical Services, Inc. (AMA) of Lanham, MD to conduct a laboratory talc survey, based on demonstrated experience with asbestos analysis in complex matrices, appropriate facilities, equipment, personnel, analytical strategy, and budget criteria. The study ran from September 28, 2009 to September 27, 2010.
How the survey was conducted
The first step was to identify cosmetic talc suppliers and talc-containing cosmetic products. We found seven talc suppliers identified in the 2008 edition of the International Cosmetic Ingredient Dictionary and Handbook and two more by searching online. The contract laboratory contacted each supplier to request samples of its talc. Of the nine suppliers identified, four complied with the request.
We found talc-containing cosmetic products to analyze by visiting various retail outlets in the Washington, D.C. metropolitan area. The samples identified for testing included low, medium, and high priced products, along with some from “niche” markets, in order to cover as broad a product range as possible. A total of thirty-four cosmetic products containing talc were selected, including eye shadow, blush, foundation, face powder, and body powder. All cosmetic products were purchased from retail stores in the Washington, D.C. metropolitan area.
The contract laboratory analyzed the samples using polarized light microscopy (PLM) and transmission electron microscopy (TEM) methods published by the New York State Department of Health, Environmental Laboratory Approval Program. Each sample was analyzed three times using both methods.
The results of FDA's survey and what they mean
The survey found no asbestos fibers or structures in any of the samples of cosmetic-grade raw material talc or cosmetic products containing talc. The results were limited, however, by the fact that only four talc suppliers submitted samples and by the number of products tested. For these reasons, while FDA finds these results informative, they do not prove that most or all talc or talc-containing cosmetic products currently marketed in the United States are likely to be free of asbestos contamination. As always, when potential public health concerns are raised, we will continue to monitor for new information and take appropriate actions to protect the public health.
The tables, found in 2010 Talc Survey Appendix, provide details for each of the cosmetic-grade raw material talc samples and cosmetic products containing talc that were analyzed in this survey. Limits of detection are shown below the table for each group of samples. Note: “NAD” means “no asbestos detected.”